Lung Cancer Early Molecular Assessment Trial (LEMA)

The investigators hypothesize that an early molecular profiling, that includes both tissue and blood-bases analysis, for all NSCLC patients, including stage I-III, will increase diagnostic efficiency. When molecular profiles are available at an earlier stage of disease, more patients will benefit from personalized therapy once needed. This will result in both a better quality of life and outcome.

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Genetic: Liquid (blood) biopsies and tumor biopsy (optional)

Detailed Description

In this prospective multicentre trial tumours of all patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing. A minimal molecular profiling is depicted but other targets will be included in due time. The study is divided in two parts. In the first part participating centres will have a run-in period of half a year in which molecular profiling is performed as is currently standard of care. This period will be used to measure the impact of increased awareness on the diagnostic process. During the second part of the study a comprehensive upfront profiling according to local standards will take place for all NSCLC patients. Liquid (blood) biopsies will be included in order to increase the diagnostic yield for those patients where tissue biopsies are not adequate. Patients will be treated according to standard of care, or included in clinical studies where appropriate. Re-biopsies (both tissue and liquid) will be advocated at the time of establishing disease progression/disseminated disease, and personalized therapy will be initiated according to the existing data from the molecular profiling.

• Study Type: Observational
• Enrollment (Anticipated): 1297

Contacts and Locations

• Study Contact: Name: Michel van den Heuvel, MD; Phone Number: 9111 0031-20-512; Email: m.vd.heuvel@nki.nl
• Study Contact Backup: Name: Robert Schouten, MSc; Phone Number: 9111 0031-20-512; Email: r.schouten@nki.nl

Study Locations

• Netherlands
  • North-Holland
    • Amsterdam, North-Holland, Netherlands, 1066CX
      • Recruiting
      • Antoni van Leeuwenhoek
      • Contact: Michael van den Heuvel, MD; Phone Number: 9111 +31-20-512; Email: m.vd.heuvel@nki.nl
      • Contact: Robert Schouten, MD; Phone Number: 9111 +31-20-512; Email: r.schouten@nki.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing

Description

Inclusion Criteria:

• Suspicion of lung carcinoma or established NSCLC but awaiting start of definitive treatment
• Written informed consent to undergo diagnostic procedure and molecular analysis of the disease.

Exclusion Criteria:

• Not motivated to receive any treatment at any point in time. Patients who consider undergoing treatment in the future are eligible.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis	Patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Include the test performance of both techniques in different stage of disease	Test performance of both techniques in different stage of disease	3 years
The percentage of patients with a predefined actionable genetic alteration	Patients with a predefined actionable genetic alteration	3 years
The costs	The costs	3 years
The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis.	Liquid biopsies on the diagnostic yield of tissue molecular	3 years

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Merck Sharp & Dohme LLC; Roche Pharma AG; AstraZeneca
• Investigators: Principal Investigator: Michel van den Heuvel, MD, Antoni van Leeuwenhoek

Publications and helpful links

General Publications

• Schuurbiers M, Huang Z, Saelee S, Javey M, de Visser L, van den Broek D, Heuvel MVD, Lovejoy AF, Monkhorst K, Klass D. Biological and technical factors in the assessment of blood-based tumor mutational burden (bTMB) in patients with NSCLC. J Immunother Cancer. 2022 Feb;10(2):e004064. doi: 10.1136/jitc-2021-004064. Erratum In: J Immunother Cancer. 2022 Sep;10(9):

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 5, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: M15LEM; NL54778.031.15 (Other Identifier: METC-AVL)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No